Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

Nausea Clinical Trial

Official title:

A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503386
• Other study ID #: HJGene_SYat-sen_06_01
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: September 16, 2010
• Start date: April 2006
• Est. completion date: October 2006

Study information

• Verified date: September 2010
• Source: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female, age = 18 yrs and <70 yrs with histologically or cytologically confirmed

• Malignant disease

• Naive or nonnaive to chemotherapy, with a Karnofsky score of = 60

• Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1

• Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit

• Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion

• Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion

• Predicted life expectancy of = 3 months

• Provision of written informed consent.

Exclusion Criteria:

• Inability to understand or cooperate with study procedures

• Receipt of investigational drugs = 30 days before study entry

• Receipt of other investigational drugs during the course of this study

• Seizure disorder or any condition requiring anticonvulsants, sedatives

• CNS malignancy or metastasis

• Ongoing emesis due to obstruction of digestive tract

• Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy

• Moderate or severe nausea and vomiting after any previous chemotherapy

• Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5

• Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5

• Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5

• Contraindications to 5-HT3 receptor antagonists

• Contraindications to chemotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy
• Nausea
• Vomiting

Intervention

Drug:
• Palonosetron

• Granisetron

Locations

Country	Name	City	State
China	Beijing Institute on Thoracic Cancer and Tuberculosis	Beijing
China	Hunan Provincial Tumor Hospital	Changsha	Hunan
China	Fujian Provincial Tumor Hospital	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The Second Hospital Affiliated to Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Provincial Tumor Hospital	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,	Sun Yat-sen University, Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)		0-24h, 24-120h , 0-120h following chemotherapy
Secondary	Major Protection from vomiting		0-24h,24-120h,0-120h following chemotherapy
Secondary	Major Protection from nausea		0-24h,24-120h,0-120h following chemotherapy
Secondary	Complete Protection from Both Vomiting and Nausea		0-24h,24-120h,0-120h following chemotherapy
Secondary	Complete Protection from Both Vomiting and Moderate-to-Severe nausea		0-24h,24-120h,0-120h following chemotherapy
Secondary	Time to First Emetic Episode		0-120h following chemotherapy

External Links

•   Publication: Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2010 Jan 5. [Epub ahead of print]